Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: X-rays- total of 4

• Registration Number: NCT04687306
• Lead Sponsor: University of Nebraska

Brief Summary

Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of spinal and/or lower extremity pathology. All radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability. Determining the reproducibility of these angles between observers will give insight into the potential clinical utility of these measurements in evaluating and treating patients with hip-spine syndrome.

Detailed Description

The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion and balance from normal healthy subjects for the purpose of establishing radiographic measurements which are reliable and reproducible and which could give insight into the potential clinical utility of these measurements as future predictors of who may/may not have spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.

This specific objective of this study will be to measure sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions. The radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability.

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-29
• Study Start: 2021-01-15
• Status Verified: 2024-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Healthy individuals without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries

Exclusion Criteria

• no history of spine/hip/pelvis issues
• females who are trying to get pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Females	X-rays- total of 4	15 females
Males	X-rays- total of 4	15 Males

Primary Outcome Measures

Name	Time	Method
Intraclass correlation coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.	One year	The intraclass correlation coefficient (ICC) will be used to evaluate the consistency of the 4 providers in measuring the sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States